FDA.reportPublic FDA data

L-Mesitran Border

Primary DI
08717249680857
Brand
L-Mesitran Border
Company
Theo Manufacturing B.V.
Model
518.10.US
Device description
L-Mesitran Border dressings are hydro-active hydrogel wound dressings containing honey.
Published
2023-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053613000L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVETheo Manufacturing BV2007-07-25FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717249680857PackageGS110In Commercial Distribution
08717249680765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717249680857087172496808578717249680857
08717249680765087172496807658717249680765

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
408656143
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717249680505L-Mesitran Tulle318.10.US2023-03-17
08717249680727L-Mesitran Active511.052023-03-17
08717249680758L-Mesitran Hydro418.10.US2023-03-17
08717249680765L-Mesitran Border518.10.US2023-03-17
08717249680833L-Mesitran Tulle318.10.US2023-03-17
87172496807278L-Mesitran Active511.052023-03-17
08717249680734L-Mesitran Soft 0.5oz203.01.US2023-03-17
08717249680741L-Mesitran Soft 1.75oz205.01.US2023-03-17
08717249680840L-Mesitran Hydro418.10.US2023-03-17

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